Kornimate/medical-research-clean huggingface dataset:
pharmacodynamic evaluation of intramuscular nalmefene autoinjector 1.5 mg compared to intranasal narcan 4 mg

Conditions: Opioid Overdose

Summary: the purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (im; into the thigh) compared to naloxone when given intranasally (in; into the nose) to healthy subjects with prior opioid exposure under steady state fentanyl concentrations (opioid agonism).


Eligibility criteria:
key inclusion criteria include: 1. healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ecg. 2. body weight ranging from 50 to 100 kg (110-220 lbs) and body mass index (bmi) within the range \[18-30\] kg/m2 (inclusive). 3. willing to be compliant with the protocol, capable of subjective evaluation, if applicable, able to read and understand questionnaires, if applicable. key exclusion criteria include: 1. females who are pregnant or lactating. 2. any significant illness during the 30 days preceding the initial dose in this study. 3. history or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion. 4. refusal to abstain from caffeine or xanthine containing beverages entirely during confinement. 5. refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration and through the end-of-study visit. 6. difficulty with venous access or unsuitable for or unwilling to undergo catheter insertion. other inclusion/exclusion criteria may apply.
usefulness of 64 slice multi-detector computed tomography as a first diagnostic approach in acute chest pain patients

Conditions: Chest Pains

Summary: the purpose of this study is to determine the usefulness of 64 slice multi-detector computed tomography as a first diagnostic approach in acute chest pain patients in emergency room

we prospectively enrolled the patients with acute chest pain who visited ed. exclusion criteria were myocardial infarction (mi) with st elevation, unstable vital sign, uncontrolled arrhythmia, renal dysfunction, hypersensitivity to contrast media and pregnancy. patients were allocated into 3 categories based on history, physical exam, and electrocardiogram: 1) definite angina with uncertainty of regarding mi (high risk), 2) probable angina (intermediate risk), 3) low likelihood of angina (low risk), and then randomized to either receive mdct immediately (mdct group), or not (control). we compared diagnostic accuracy, length of stay in er, admission rate, and major adverse cardiac events (mace) and clinical diagnosis in 1 month after discharge from ed.

Eligibility criteria:
inclusion criteria: * acute chest pain patient visiting emergency room exclusion criteria: * unstable vital sign * renal failure * st elevation myocardial infarction * uncontrolled arrhythmia * hypersensitivity to contrast dye * clinically no possibility of angina

Keywords: chest pains computed tomography emergency
combined ultrasound and fluoroscopy guided cervical transforaminal injection

Conditions: Chronic Cervical Radicular Pain

Summary: the combined use of doppler ultrasound and fluoroscopy may increase efficacy and safety during cervical transforaminal epidural injection of steroid and local anaesthetic the study will detect by which technique we have to start and confirm by the other to reach the favourable outcome.

in a previous ultrasound study involving the c5c6 levels, a performance time of 248.8 ± 82.7 seconds was reported. on the basis of these findings, a 30% difference in performance time would represent an effect size of 0.82 and would require 20 patients per group to achieve an alpha error of 0.05 and beta error of 0.1. for dropped cases; 5% will be added. so a total sample size of 64 patients (32 per group) will be required. statistical analysis: will be performed using spss version 22 statistical software. for quantitative data, normality will be first assessed with the shapiro test and then analyzed with the student t-test. data that will not have a normal distribution, as well as ordinal data, will be analyzed with the mann-whitney u test. for binomial data, fisher exact test will be used. all p values presented will be 2-sided and values of less than 0.05 will be considered significant.

Eligibility criteria:
inclusion criteria: * patients suffering from radicular discogenic pain * patients suffering from radicular foraminal pain patients suffering from radicular pain secondary to spinal canal stenosis * patients suffering from radicular pain after failed cervical disc surgery * not responding to conservative management for at least 3 months * patients with recalcitrant symptoms after transforaminal steroid injection. * american society of anesthesiology (asa) from i to iii exclusion criteria: * presence of local or systemic infection * coagulopathy * body mass index \> 35 * cervical spine fracture * myelopathy * malignancy * pregnancy * patients unable to communicate with the operator during the procedure or report their pain diary after it. * patients not responding to previous cervical transforaminal steroid injection or had any untoward effects. * allergy to any one of the used medications.
does ketamine attenuate depression of respiratory and cardiac functions

Conditions: Congenital Heart Disease; Sedated for Cardiac Catheterization

Summary: normal cardiac and respiratory functions should be maintained during pediatric cardiac catheterization. propofol has become a popular choice for sedation in children, however, it depresses cardiac and respiratory functions. some investigators reported that ketamine attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and respiratory depression caused by propofol in pediatric cardiac catheterization.


Eligibility criteria:
inclusion criteria: * 7kg-25kg (6mo-10yrs) children who undergo cardiac catheterization exclusion criteria: * patients who have neurological disease, * endocrinological disease, * airway anomaly, who require positive pressure ventilation

Keywords: children sedation propofol ketamine
postoperative pain following irrigation with endodontic needle, sonic and passive ultrasonic techniques

Conditions: Tooth,Non-vital

Summary: the aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.

different irrigation delivery systems are introduced to the market aiming to improve root canals disinfection. the conventional endodontic needle is commonly used because of its ease in use and good control of needle depth and irrigant volume. however it carries a higher risk of extruding the solution periapically because of positive pressure used in solution delivery. passive ultrasonic irrigation is a noncutting irrigation technique that is done with ultrasonically activated files with continuous or intermittent flow of irrigant. it was shown that it is effective in removing remnants of pulp tissue, dentin debris and planktonic bacteria. the vibringe (cavex holland bv, haarlem, the netherlands) is an irrigation device that combines manual delivery and sonic activation of the irrigant. the aim of this study is to compare the postoperative pain after root canal treatment following irrigation by endodontic needle, sonic and passive ultrasonic irrigation techniques.

Eligibility criteria:
inclusion criteria: * males or females * age between 16-60 years old * permanent mandibular molars with: * non-vital response of pulp tissue * absence of spontaneous pain exclusion criteria: * pregnant females * patients having significant systemic disorder * patients received analgesics, anti-inflammatory or antibiotic in the last 24 hours * teeth that have: * vital pulp tissues * association with swelling or fistulous tract * acute periapical abscess * greater than grade i mobility * pocket depth greater than 5mm * previous endodontic treatment
real-time automated program for identification of vt origin

Conditions: Ventricular Tachycardia; Ischemic Heart Disease

Summary: rapid-vt pilot is a single centre prospective cohort pilot study to assess the feasibility, safety and efficacy of catheter ablation of ventricular tachycardia (vt) guided by a novel real-time software to localize the origin of vt during the ablation procedure.

consecutive patients with ischemic heart disease and clinical indication of vt ablation will undergo baseline clinical evaluation, echocardiography and cardiac ct imaging using a contrast-enhanced cardiac-gated method with a 64-section scanner. trans-axial ct images comprising the whole heart volume will be exported in dicom format. ct image processing will be performed and will be used to delineate the lv endocardial and/or epicardial geometries. these data will be imported into the rapid-vt software and the 3d-electranatomical mapping system for image integration. during the vt ablation procedure, vt(s) induction will be performed. the vt(s) 12-lead ecg will be acquired by the rapid-vt software and will be localized to the scar margin using the rapid-vt software. catheter ablation will be attempted at software-determined sites. post procedure, patient will be followed up for a minimum of 6 months. that will include remote icd follow-up and telephone study visits. follow-up at 6 months will include a clinic visit for assessment of heart failure status, ecg, icd interrogation and changes in antiarrhythmic drug therapy.

Eligibility criteria:
inclusion criteria: * patients will be eligible for inclusion if they fulfilled vanish inclusion criteria by having both of: 1. prior myocardial infarction (pathological q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause)38 and 2. one of the following vt events within the last 6 months while on amiodarone or another class iii or class i antiarrhythmic drug: a: sustained monomorphic vt documented on 12-lead ecg or rhythm strip requiring termination by pharmacologic means or dc cardioversion, b: ≥3 episodes of symptomatic vt treated with anti-tachycardia pacing (atp), c: ≥1 appropriate icd shocks, d: ≥3 vt episodes within 24 hours, separated by ≥ 5 minutes, e: sustained vt below detection rate of an icd exclusion criteria: * patients will be excluded from the trial if they: 1. are unable or unwilling to provide informed consent. 2. have active ischemia or another reversible cause of vt (e.g. drug-induced arrhythmia), or had recent acute coronary syndrome requiring revascularization. 3. are antiarrhythmic drug-naïve. 4. are known to have protruding left ventricular thrombus or mechanical aortic and mitral valves. 5. have had a prior catheter ablation procedure for vt. 6. are in renal failure (creatinine clearance \<15 ml/min) 7. have nyha functional class iv heart failure or ccs functional class iv angina. 8. have had recent st elevation myocardial infarction (\< 1 month). 9. are pregnant or have a systemic illness likely to limit survival to \<1 year.

Keywords: catheter ablation ecg imaging
a study of cytomegalovirus disease epidemiology in pediatric and adult liver transplant recipients in china

Conditions: Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China

Summary: the goal of this observational study is to learn about cytomegalovirus disease epidemiology in pediatric and adult liver transplant recipients in china. the main questions it aims to answer are: * the incidence of cytomegalovirus (cmv) infections (including clinical significant cmv reactivations and cmv diseases) among children and adults liver transplantation patients in china * all-cause mortality (survival probability at 1 year) * incidence of allograft rejection. number of subjects with allograft rejection * graft loss. incidence of graft loss (re-transplantation) * late-onset cmv disease. incidence of late-onset cmv disease (occurring after 100 days post-randomization) as adjudicated by end point committee * bacterial infections. incidence of bacterial opportunistic infections * major fungal infections. opportunistic fungal infections * major non-cmv viral infections. incidence of non-cmv viral infections we will collect demographic data of participants. all recipients and donors underwent preoperative testing for cmv pp65 antigenemia, plasma cmv dna, and serum cmv antibody. all the recipients were followed up in a liver transplant follow-up clinic twice weekly for a month after discharge from hospital. after that, patients were followed up weekly for 3 months, fortnightly for 6 months, and monthly for 12 months.


Eligibility criteria:
inclusion criteria: * have received their first orthotopic liver transplant (the transplanted liver may be deceased donor or live donor graft) within 10 days prior. * children group: age ≤18yeas； * adults group: age \>18yeas； * willingness to participate in the study * ability to understand information material * written informed consent exclusion criteria: * have known human immunodeficiency virus (hiv) infection (based on testing performed during the transplant evaluation process). * participation in another investigational agent trial * be undergoing multi organ transplant or have undergone prior organ transplant. have expected life expectancy of less than 72 hours.

Keywords: cytomegalovirus children adult liver transplantation
efficacy study of il-21 to treat metastatic melanoma

Conditions: Cancer; Malignant Melanoma

Summary: this trial is conducted in oceania. a phase 2a study to assess the effect on tumor size. at least 14 to a maximum of 40 patients, who have not previously received treatment for their stage iv disease, will be treated for 6 weeks. il-21 will be administered intravenously.


Eligibility criteria:
inclusion criteria: * histologically confirmed surgically incurable metastatic melanoma * patients must have measurable disease * ecog performance status of 0 or 1 * expected life expectancy at least 4 months exclusion criteria: * history of and signs/symptoms of uncontrolled brain metastases or edema. * previous treatment with chemotherapy or any biological anti-cancer drug (prior adjuvant therapy with interferon-alpha is permitted as long as treatment was completed at least six months prior to study entry.) * radiotherapy: radiation therapy within 4 weeks prior to entering the study. * receipt of any investigational drug for treatment of metastatic melanoma prior to this trial.
effect of intensive motor rehabilitation in subacute stroke patient

Conditions: Stroke; Rehabilitation; Motor Function

Summary: early stroke rehabilitation is known to be an effective and essential therapy in gaining functional independence and preventing complications. however, there was no consensus of proper amount of motor rehabilitation in stroke patients. in this study, the investigators investigated the effects of the intensive motor rehabilitation during subacute phase to improve motor function at 6 months after onset in patients with first-ever strokes.

intensive cognitive rehabilitation group - physical and occupational therapy for 3 hours on every working day for 2 weeks

Eligibility criteria:
inclusion criteria: * acute first-ever stroke * upper limb score of fugl-meyer assessment at 7 days after onset : 25\~84 exclusion criteria: * transient ischemic stroke * joint contracture of affected upper extremity
safety and efficacy of home-based hospitalization versus inpatient care for patients with acute heart failure in chronic heart failure.

Conditions: Heart Failure

Summary: evaluation of the efficacy, safety and and cost of home care versus conventional hospitalization care at 3-months in patients with worsening chronic heart failure.

chronic heart failure (chf) has an important socio-economic impact due to frequent hospital readmissions. hypothesis: home care treatment (hc) will improve quality of live and decrease cost. methodology: pilot, prospective, open, randomized controlled trial with 1-year follow-up for chf patients admitted to 10 french hospital from march 2017 through february 2018, for acute decompensation of chf. patients will be randomly assigned to conventional hospital care or to the hc and treated with intravenous diuretics. following discharge within 48 hours from the hospital, patients in the hc group will be treated at home. follow-up will be conducted for both groups at discharge, 3 and 12 months after inclusion in the study.

Eligibility criteria:
inclusion criteria: * acute heart failure (with history of chronic heart failure) * identified in the first 48 hours * eligible for home-care with "hospitalisation à domicile" within 4 days after hospitalization. * patient affiliated to social security and to complementary health insurance exclusion criteria: * under 18 years old * predominantly left-sided heart failure, dependent on oxygen because of the congestion * unexplored heart failure, indication of specific techniques (angiography) of device implantations (icd, crt). * severe cognitive disorders. behavior disorders. * severe renal dysfunction with egfr (mdrd) \< 15 ml/min/1.73m2 * patient leaving alone

Keywords: acute heart failure chronic heart failure home care services cost-benefit analysis quality of life
a study evaluating 13-valent pneumococcal conjugate vaccine (13vpnc) in healthy infants in china

Conditions: Pneumococcal Infection

Summary: this study is primarily designed to evaluate the igg immune responses to the 13 pneumococcal serotypes induced by 13vpnc compared with the immune responses induced by 7vpnc when measured 1 month after the infant series, and to evaluate the acceptability of the safety profile of 13vpnc as measured by the incidence rates of local reactions, systemic events and adverse events.


Eligibility criteria:
inclusion criteria: 1. aged 42 to 77 days (approximately 2 months) at the time of enrollment. 2. healthy infant as determined by medical history, physical examination, and judgment of the investigator. exclusion criteria: 1. previous vaccination with licensed or investigational pneumococcal vaccine. 2. a previous anaphylactic reaction to any vaccine or vaccine-related component. 3. contraindication to vaccination with pneumococcal vaccines.

Keywords: 13vpnc 7vpnc healthy subjects china
placental expression of eg-vegf and its prokr1 and prokr2 receptors in preeclampsia patients.

Conditions: Preeclampsia

Summary: the pathophysiology of preeclampsia (pe) is thought to be endothelial dysfunction responsible for the maternal signs of de novo hypertension and proteinuria after 20 weeks. current concepts suggest that the pathophysiology of preeclampsia and intrauterine growth retardation results from an imbalance of angiogenic factors. a new angiogenic factor eg-vegf (endocrine gland- derived vascular endothelial growth factor) also known as prokineticin 1 (prok1) appears to be emerging in the pathophysiology of pe. eg-vegf is a circulating factor which belongs to the family of prokinetics. dr alfaidy's mab2 team at the cancer and infections biology laboratory (u1292 biosanté inserm / uga / cea, cea grenoble) demonstrated its key role in the control of key processes in placental development and provided evidence through the development of an animal model of preeclampsia. eg -vegf is directly involved in the development of pre-eclampsia. few studies have evaluated the expression of eg-vegf in the human placenta.


Eligibility criteria:
inclusion criteria: * all patients who have given birth by cesarean section at the maternity university hospital saint etienne and all underwent a placenta pathological examination at the saint etienne university hospital. * for the pre-eclampsia group: patient with a diagnosis of pre-eclampsia * for the control group: patient who had a normal pregnancy exclusion criteria: * patient who gave birth naturally * underage patients or under guardianship * patients who do not speak or read french * childbirth under x

Keywords: preeclampsia eg-vegf prokineticin cesarean placenta pathological examination pregnancy prok1 receptor prokr2 receptor
study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions

Conditions: Coronary Artery Disease

Summary: this study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.

the bifurcated coronary lesions are still a challenge for interventional cardiologists, since there is no suitable technique or strategy to manage such lesions. this multicenter randomized prospective trial in bifurcated coronary lesions will compare the new technology of the paclitaxel-eluting balloon with the until now "gold standard" technique of the "provisional stenting" with the paclitaxel des in the main branch.

Eligibility criteria:
inclusion criteria: patients * patients with stable angina (1-3) or unstable angina (1-3 a-c) or documented silent ischemia * patients with mental and logistic conditions for the follow-up * patients should accept an angiographic follow-up at 9 months, a clinical follow-up at 3 years and sign the consent lesions * de-novo lesions in the bifurcations of da/diag either cx/om or cd/dp with diameters in the main vessel of 2,5 to 3,8/ 2 to 3,5 and lengths \< 22 mm * the left main lesions in bifurcation are also accepted but with another independent randomization list (specify at randomization) * the diameter of the stenoses should be \>50% in any branch with documented ischemia or more than 70% in absence of an ischemia test * single vessel or multivessel disease * in case of a ptca of more than one lesion, the non included lesion should be treated previously to the included lesion exclusion criteria: patients * patients with stemi \< 72 hours * patients with congestive heart failure or nyha iv, shock or severe valvular heart disease * patients with short life expectancy, or with problems for platelet antiaggregation * patients in treatment with hyperthyroidism, in treatment with immunosuppression or anticoagulants, or with alcohol or drug addiction * patients included in other trials * patients with a stroke 6 months before * patients with a surgery one week before * severe renal failure calculated as gf \< 30 ml/min "cockcroft gault" * women of childbearing age, with probability to become pregnant during the first year of follow-up lesions * evidence of important thrombus within the vessel to treat * patients with another stent previously implanted at ≤ 15 mm from the current lesion of the study * lesions affecting bypass * chronic occlusions to treat * restenosis in-stent or of a segment in 4 mm close to the target lesion * severe calcification not totally dilatable with the balloon

Keywords: coronary stenosis bifurcation drug-eluting balloon drug-eluting stent angiographic follow-up late lumen loss restenosis